Panels › Gastroenterology, Urology › Product code EZW · Class 3
Stimulator, Electrical, Implantable, For Incontinence
Regulation 876.5270
0510(k)s in 12 months (0 all time)
2recalls in 12 months (11 all time)
0recalls that name a 510(k)
Top companies in EZW
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Neuromodulation | 0 | 10 |
| Axonics, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | Medtronic Neuromodulation InterStim Percutaneous Extensions
EXT 3560022 ISTM II PERC
3560022
EXT 3560030 ISTM MICRO PERC
3560030 Open, Classified |
EZW | None listed |
| Oct 16, 2026 | Axonics, Inc. PNE Lead Implant Kit
REF: 1701 Open, Classified |
EZW | None listed |
| Apr 30, 2025 | Medtronic Neuromodulation Enhanced Verify Evaluation Handset (CFN HH90130FA) Open, Classified |
EZW | None listed |
| Sep 6, 2024 | Medtronic Neuromodulation Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator. Open, Classified |
EZW | None listed |
| Aug 10, 2023 | Medtronic Neuromodulation Medtronic InterStim Ground Pad REF 041826 Open, Classified |
EZW | None listed |
| Apr 22, 2022 | Medtronic Neuromodulation MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) Inte Terminated |
EZW | None listed |
| Nov 4, 2021 | Medtronic Neuromodulation Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator. Open, Classified |
EZW | None listed |
| Jun 7, 2019 | Medtronic Neuromodulation InterStim(TM) System, Model Numbers:
a) TH90G01
b) TH90GFA
c) TH90G02
d) TH90G03
Product Usage:
The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Open, Classified |
EZW | None listed |
| Sep 20, 2008 | Medtronic Neuromodulation Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantabl Terminated |
EZW | None listed |
| Oct 12, 2007 | Medtronic Neuromodulation Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Progra Terminated |
EZW | None listed |
| Oct 11, 2007 | Medtronic Neuromodulation Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator Terminated |
EZW | None listed |
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